Effective Quality Assurance Auditing



תאריך: 28 אוקטובר 2012
מיקום הקורס: כפר המכביה, רמת גן
קטגוריה: איכות , מומחים מחו"ל
מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
עלות: 2,150 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 12456
שפת הקורס: אנגלית
על הקורס

The need for quality assurance auditing has been recognized in, and is a requirement of, the ICH-Q7A API GMPs for manufacturers of active pharmaceutical ingredients; the US Quality System Regulations (21CFR820) for manufacturers of medical devices and equipment; the Good Clinical and Laboratory Practices regulations (GLPs and GCPs); and WHO, European, and American Pharmaceutical GMPs. Quality Assurance Auditing is a cornerstone of ISO 9000 Quality Systems, but now also plays a central role in FDA’s new 21st century GMP initiative. Without an effective audit program, compliance with quality standards and European and American GMPs is impossible.

Experience reveals that many internal company audits and many external supplier/contractor audits are less than effective in instigating change and waste much time and money. This course provides the rationale, strategies, techniques and tips for planning and performing effective quality assurance audits.

The course explores the politics, psychology and technical aspects of auditing, as well as the logistics, tools and recommended frequency of audits. The course evaluates the talents and personal characteristics required of a good auditor and compares them to those required of an excellent auditor.

The ultimate goal is to effect change. Determining operational deficiencies is only one aspect of an audit. Just as important is helping bring about compliance to company and legal standards. This course provides the tools required to make audits a positive experience for the auditor and for the auditee, and to ensure that the company gains maximum benefit.

קהל היעד

This seminar is designed for quality managers, auditors, production managers and top management interested in learning the value of a good audit, how to prepare for a good audit and how to enhance QA Auditing as a valuable quality assurance tool. Consultants and government inspectors will find this course particularly useful in enhancing their inspections capabilities

התועלת שתופק
  • know what is involved with an effective quality assurance audit, and how to plan for its successful implementation
  • understand what FDA and EU authorities expect from internal and external audits and know how effective audits fit into FDA’s 21st century GMP initiative
  • Understand what demands EU authorities place on pharmaceutical manufacturers to audit their API suppliers
  • recognize why quality assurance audits are necessary, how to perform audits and how to get the most out of them
  • be able to sell management on implementing effective internal audits and supplier/contractor audits
  • be aware of the politics of audits, and know how not to alienate your audit host or jeopardize your career
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Audit Mechanics: Preparation, performance, conclusion, audit reports and follow-up, effecting change. The pluses and minuses of surprise audits. The How To's and How Not To's of performing audits.
  • Audit Reports: Forms design, advantages and disadvantages of audit checklists, grading lists, open-ended report formats.
  • Contractor and Supplier Audits: Design and process defects, supplier auditing, new audits and problem resolution audits.
  • Overview and General Considerations: The true costs of quality, including product and process failure. The purpose of quality assurance audits (QAA). The role of QAA in healthcare manufacturing operations in the 2000s. Interactions between QA and purchasing, product development, production and quality control. The QAA function and its reporting relationship within the organization. The politics of auditing.
  • Types of Audits: Internal facility audits; product, process and system audits; audits of contract manufacturers and laboratories; supplier/vendor audits. Strategies and techniques to maximize audit effectiveness, and effect change.
  • Audit Standards: US-FDA GMPs, EU GMPs, ISO 9000 — similarities and differences in expectations and standards.
  • What Makes A Good Audit: Audit objectivity, auditing standards, auditor qualifications and training. Creating a win-win audit — turning the audit into a positive coaching experience for yourself, your company and those you are auditing.
  • Selling Quality Assurance Audits To Management: Speak the language of top management, and get them to listen, buy in and take action on your findings
אודות המרצה

Mr. Michael Anisfeld

is senior consultant for Globepharm Consulting specializing in GMP/Quality activities for the healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies, national regulatory agencies (including the US-FDA) and more than 200 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in North America, Europe and Asia.

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